The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Cardiac Trigger Monitor.
| Device ID | K202138 |
| 510k Number | K202138 |
| Device Name: | Cardiac Trigger Monitor |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405 |
| Contact | Alejandra Aceves |
| Correspondent | Alejandra Aceves Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-31 |
| Decision Date | 2021-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816396023222 | K202138 | 000 |
| 00816396022874 | K202138 | 000 |
| 00816396022881 | K202138 | 000 |
| 00816396023079 | K202138 | 000 |
| 00816396021495 | K202138 | 000 |
| 00816396022898 | K202138 | 000 |
| 00816396022904 | K202138 | 000 |
| 00816396022928 | K202138 | 000 |
| 00816396022935 | K202138 | 000 |
| 00816396023062 | K202138 | 000 |
| 00816396023086 | K202138 | 000 |
| 00816396023208 | K202138 | 000 |
| 00816396023215 | K202138 | 000 |
| 00816396022867 | K202138 | 000 |